NEW YORK, March 26, 2020 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced the rescheduling of its advisory committee meeting (AdCom) by the U.S. Food and Drug Administration (FDA), provided an update on expected first quarter 2020 financial performance, and announced new initiatives intended to ensure business continuity and support its employees amid the evolving COVID-19 pandemic, all while continuing the critical work necessary to bring its approved medicines to the patients who need them.
Regulatory Update.Amid the evolving COVID-19 pandemic, the FDA has notified us that it has rescheduled the previously announced AdCom related to our New Drug Application (NDA) for obeticholic acid (OCA) in liver fibrosis due to nonalcoholic steatohepatitis (NASH). The AdCom which had previously been tentatively scheduled for April 22, 2020, is now tentatively scheduled for June 9, 2020. We continue to work closely with the FDA on our priority review application and our Prescription Drug User Fee Act (PDUFA) target action date for the NDA remains June 26, 2020. We also continue to work collaboratively with the European Medicines Agency (EMA) on its review of our Marketing Authorization Application (MAA) for liver fibrosis due to NASH submitted in December 2019.
Clinical Trials Update. We are focused on ensuring patient safety and maintaining the integrity of our ongoing clinical trials. We are monitoring the COVID-19 situation very closely and together with our contract research organizations, study sites and other partners, have taken measures intended to minimize any disruption to our ongoing trials. Our pivotal Phase 3 NASH studies, REGENERATE and REVERSE, are fully enrolled and our focus is to provide needed support to participating sites and patients around the world. With respect to our ongoing PBC studies, under the current circumstances we are additionally temporarily pausing screening and randomization of patients in certain of our continuing studies of OCA in PBC.
Financial Update.Our PBC business has continued to perform well during the first quarter and our preliminary view indicates net sales are expected to be generally in line with those in the fourth quarter of 2019. In addition, we are reconfirming our previously announced non-GAAP adjusted operating expenses guidance for the full year 2020. We are investing to support the launch of OCA for liver fibrosis due to NASH, our commercial efforts in primary biliary cholangitis (“PBC”), our clinical development and pipeline programs and our other operating activities. Our non-GAAP adjusted operating expenses guidance continues to assume the approval of our NDA for liver fibrosis due to NASH by the FDA on or about our PDUFA target action date.
Supply Chain Update.Ensuring patient access to Ocaliva® (obeticholic acid or OCA) for patients with PBC is of paramount importance, particularly during these unprecedented times. We are working closely with our third-party manufacturers, distributors and other trusted partners to manage our supply chain activities and mitigate any potential disruptions to our product supplies as a result of COVID-19.
Employee Update. We support broader public health strategies designed to prevent the spread of COVID-19 and are focused on the health and welfare of our employees. In accordance with guidance issued by the Centers for Disease Control and Prevention (CDC), the World Health Organization (WHO) and local authorities, Intercept’s global workforce, both office and field-based employees, are working remotely from home until further notice. We are now leveraging digital communication technologies to continue important interactions with healthcare professionals, patients and other stakeholders.
As we, along with the rest of the world, navigate these unprecedented circumstances, we are committed to continuing to implement measures intended to minimize any potential business impact from COVID-19 and will continue to closely monitor, assess and respond to the situation as it evolves.
About Ocaliva® (obeticholic acid)
Ocaliva is indicated in the United States for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA.
